MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that no continuity in the circuit was confirmed during continuity test before the catheter insertion.The issue was resolved by replacing the catheter.Information such as the background of malfunction occurrence, what kind of surgery and examination the catheter was used for or if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.Although visual examination by the sales rep revealed that blood like stain was present around between 20cm and 30cm on the catheter body, it was confirmed that the catheter had not been inserted to the patient.There were no patient complications reported.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

Manufacturer Narrative

The reported event of no continuity in the circuit was confirmed.Continuity testing found that a short condition occurred between the proximal and distal circuits.No open or short condition was observed in the lead wires between distal side of y adaptor and the electrodes.No visible damage was observed from catheter body, balloon, and windings.The balloon inflated clear and concentric and remained inflated for 5min.Without leakage.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15245639
• MDR Text Key: 298200022
• Report Number: 2015691-2022-07380
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/06/2024
• Device Model Number: PE074F5
• Device Lot Number: 64286849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1